Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 25131224 |
US |
1 | |
Drug dose omission by device, Device leakage, Device malfunction, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 102 | 25131930 |
CA |
||
Foot operation, Device malfunction, Arthralgia, Product use issue, Therapy interrupted, Drug dose omission by device, Intentional dose omission, |
||||
ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, FOLIC ACID, HYDROXYCHLOROQUINE SULFATE, |
||||
| 103 | 25132019 |
US |
67 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 104 | 25121302 |
US |
75 | |
Drug dose omission by device, Wrong technique in product usage process, Off label use, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 105 | 25121309 |
US |
78 | |
Cough, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 106 | 25121420 |
US |
79 | 2 |
Device difficult to use, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device, Nasopharyngitis, |
||||
EVOLOCUMAB, |
||||
| 107 | 25121464 |
US |
||
Incorrect dose administered by device, Overdose, Drug dose omission by device, Device delivery system issue, Device malfunction, Device use issue, Visual impairment, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 108 | 25121921 |
US |
28 | 2 |
Drug dose omission by device, Incorrect dose administered by device, Exposure via skin contact, Needle issue, Device malfunction, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 109 | 25121937 |
US |
52 | 2 |
Drug dose omission by device, Migraine, Injection site pain, Injection site urticaria, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 110 | 25122191 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 111 | 25122204 |
US |
73 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 112 | 25122216 |
US |
61 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, LEVOTHYROXINE, ATENOLOL, CHLORTHALIDONE, |
||||
| 113 | 25122251 |
US |
||
Dyspnoea, Drug dose omission by device, Device delivery system issue, Device breakage, |
||||
ALBUTEROL SULFATE, |
||||
| 114 | 25122364 |
US |
60 | 2 |
Muscle spasms, Device difficult to use, Drug dose omission by device, Product administration error, Product communication issue, |
||||
EVOLOCUMAB, |
||||
| 115 | 25122943 |
US |
||
Drug dose omission by device, Device delivery system issue, Device use issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 116 | 25123029 |
US |
68 | |
Incorrect dose administered by device, Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, |
||||
| 117 | 25123732 |
US |
47 | |
Drug dose omission by device, Product preparation error, Wrong technique in device usage process, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 118 | 25123895 |
US |
||
Wrong technique in product usage process, Device deposit issue, Drug dose omission by device, Extra dose administered, Drug ineffective, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 119 | 25123972 |
US |
45 | |
Device delivery system issue, Drug dose omission by device, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 120 | 25124028 |
US |
74 | 1 |
Blood glucose increased, Drug dose omission by device, Device mechanical issue, |
||||
INSULIN GLARGINE, |
||||
| 121 | 25124236 |
US |
76 | |
Asthma exercise induced, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 122 | 25124309 |
US |
48 | 2 |
Incorrect dose administered by device, Needle issue, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 123 | 25124632 |
US |
||
Oropharyngeal discomfort, Muscular weakness, Pain in extremity, Dyspnoea, Fatigue, Product use issue, Drug dose omission by device, Taste disorder, |
||||
| 124 | 25125266 |
US |
17 | 1 |
Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 125 | 25125268 |
US |
13 | 1 |
Drug dose omission by device, Device defective, |
||||
SOMATROPIN, |
||||
| 126 | 25125271 |
US |
15 | 2 |
Drug dose omission by device, Device use error, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 127 | 25125288 |
US |
84 | 2 |
Chondrocalcinosis, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 128 | 25125515 |
US |
13 | 1 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 129 | 25125516 |
US |
14 | 1 |
Drug dose omission by device, Device leakage, Device use issue, |
||||
SOMATROPIN, |
||||
| 130 | 25125525 |
NL |
||
Device failure, Drug dose omission by device, |
||||
EPINEPHRINE, |
||||
| 131 | 25125572 |
US |
42 | 2 |
Device difficult to use, Product communication issue, Drug dose omission by device, Therapy interrupted, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 132 | 25125635 |
BR |
||
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, |
||||
| 133 | 25125696 |
GB |
5 | 1 |
Device physical property issue, Drug dose omission by device, Incorrect dose administered by device, |
||||
SOMATROPIN, |
||||
| 134 | 25125699 |
US |
||
Drug dose omission by device, Device defective, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 135 | 25125700 |
CL |
6 | 1 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 136 | 25125763 |
CO |
1 | |
Drug dose omission by device, Product colour issue, |
||||
SOMATROPIN, |
||||
| 137 | 25125777 |
US |
12 | 1 |
Drug dose omission by device, Device physical property issue, Poor quality device used, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 138 | 25125810 |
CO |
2 | |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 139 | 25126085 |
US |
80 | 2 |
Renal disorder, Cough, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 140 | 25126108 |
US |
67 | 1 |
Device difficult to use, Drug dose omission by device, Therapy interrupted, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 141 | 25115618 |
US |
90 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 142 | 25115790 |
US |
79 | 2 |
Drug dose omission by device, Device adhesion issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 143 | 25115962 |
US |
1 | |
Drug dose omission by device, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 144 | 25116048 |
US |
77 | 2 |
Device difficult to use, Drug dose omission by device, Device use error, |
||||
ERENUMAB-AOOE, |
||||
| 145 | 25116091 |
US |
68 | 2 |
Diarrhoea, Drug dose omission by device, Tachycardia, Device malfunction, Device issue, Device leakage, |
||||
TERIPARATIDE, |
||||
| 146 | 25116403 |
US |
56 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 147 | 25116420 |
US |
||
Dyspnoea, Cough, Wheezing, Drug dose omission by device, Device delivery system issue, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 148 | 25116440 |
US |
22 | 2 |
Device difficult to use, Drug dose omission by device, Therapy interrupted, Product communication issue, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 149 | 25116446 |
US |
||
Wrong technique in product usage process, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 150 | 25116473 |
US |
59 | |
Drug dose omission by device, Product use in unapproved indication, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 151 | 25116475 |
US |
2 | |
Illness, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 152 | 25116483 |
US |
29 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 153 | 25116526 |
IT |
11 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 154 | 25116559 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 155 | 25116574 |
US |
28 | |
Dyspnoea, Insomnia, Dizziness, Adverse event, Drug dose omission by device, Device delivery system issue, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 156 | 25116617 |
AU |
77 | 1 |
Death, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 157 | 25116646 |
US |
67 | |
Drug dose omission by device, Wrong technique in product usage process, Product use in unapproved indication, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 158 | 25116667 |
US |
66 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 159 | 25116882 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 160 | 25116935 |
US |
80 | 2 |
Breast cancer, Ill-defined disorder, Memory impairment, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 161 | 25117451 |
US |
66 | |
Drug dose omission by device, Device deposit issue, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 162 | 25117490 |
US |
75 | 1 |
Device difficult to use, Wrong technique in product usage process, Migraine, Product communication issue, Drug dose omission by device, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 163 | 25117865 |
US |
70 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 164 | 25117878 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 165 | 25117924 |
US |
58 | 2 |
Rheumatoid arthritis, Migraine, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 166 | 25118074 |
US |
||
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 167 | 25118096 |
US |
57 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 168 | 25118158 |
US |
13 | 1 |
Device physical property issue, Device use error, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 169 | 25118192 |
US |
64 | |
Dyspnoea, Device delivery system issue, Drug dose omission by device, Device deposit issue, |
||||
ALBUTEROL SULFATE, |
||||
| 170 | 25118287 |
US |
65 | 2 |
Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 171 | 25118330 |
US |
10 | 1 |
Off label use, Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 172 | 25118331 |
US |
13 | 2 |
Injection site discomfort, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, NORETHINDRONE ACETATE/ETHINYL ESTRADIOL, |
||||
| 173 | 25118338 |
US |
14 | 1 |
Drug dose omission by device, Device mechanical issue, Device defective, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 174 | 25118339 |
TR |
||
Drug dose omission by device, Device mechanical issue, |
||||
ETANERCEPT, |
||||
| 175 | 25118380 |
US |
14 | 2 |
Drug dose omission by device, Device use issue, Device information output issue, |
||||
SOMATROPIN, |
||||
| 176 | 25118600 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 177 | 25118658 |
US |
64 | 2 |
Cardiac failure congestive, Device difficult to use, Product communication issue, Drug dose omission by device, Emphysema, |
||||
EVOLOCUMAB, EVOLOCUMAB, FUROSEMIDE, |
||||
| 178 | 25118881 |
US |
54 | 2 |
Drug dose omission by device, Product storage error, |
||||
SOMATROPIN, |
||||
| 179 | 25118917 |
US |
13 | 2 |
Drug dose omission by device, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 180 | 25119856 |
US |
13 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 181 | 25119886 |
US |
2 | |
Needle issue, Accidental exposure to product, Drug dose omission by device, |
||||
OFATUMUMAB, |
||||
| 182 | 25120125 |
US |
2 | |
Drug dose omission by device, Device issue, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, |
||||
| 183 | 25120174 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 184 | 25120541 |
AE |
2 | |
Device loosening, Drug dose omission by device, |
||||
FILGRASTIM, |
||||
| 185 | 25120819 |
US |
76 | 2 |
Injection site pain, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 186 | 25120910 |
US |
74 | 1 |
Blood cholesterol decreased, Device difficult to use, Off label use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 187 | 25109877 |
US |
72 | 2 |
Dry eye, Visual impairment, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 188 | 25109886 |
US |
68 | 2 |
Injection site pain, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 189 | 25110233 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 190 | 25110294 |
US |
61 | 1 |
COVID-19, Injection site pain, Product communication issue, Accidental exposure to product, Drug dose omission by device, |
||||
EVOLOCUMAB, ADALIMUMAB, |
||||
| 191 | 25110555 |
US |
79 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, THEOPHYLLINE, TIOTROPIUM BROMIDE, FLUTICASONE PROPIONATE, |
||||
| 192 | 25110723 |
US |
||
Dyspnoea, Injection site pain, Drug dose omission by device, Device delivery system issue, Wrong technique in device usage process, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 193 | 25110725 |
US |
59 | 2 |
Hypoacusis, Drug dose omission by device, Expired device used, |
||||
ETANERCEPT, |
||||
| 194 | 25110813 |
US |
60 | |
Dyspnoea, Respiratory disorder, Asthma, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 195 | 25110904 |
US |
46 | 2 |
Device leakage, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 196 | 25111019 |
US |
23 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, |
||||
| 197 | 25111034 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 198 | 25111096 |
US |
||
Wheezing, Drug dose omission by device, Product use in unapproved indication, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 199 | 25111119 |
US |
||
Drug dose omission by device, Circumstance or information capable of leading to device use error, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 200 | 25111148 |
US |
49 | 2 |
Renal cancer, Grip strength decreased, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2025-04-28